Using sensory testing to predict treatment response in chronic pancreatitis

QST Study: Predicting Treatment Response in Chronic Pancreatitis Using Quantitative Sensory Testing

This study is testing if a special pain sensitivity test can help predict how well people with chronic pancreatitis will respond to different treatments.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 500 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Pittsburgh (other)
• Locations: 2 sites (Baltimore, Maryland and 1 other locations)
• Trial ID: NCT03434392 on ClinicalTrials.gov

What this trial studies

This study employs Quantitative Sensory Testing (QST) to evaluate pain patterns in patients with Chronic Pancreatitis (CP). By applying standardized stimulations, the study aims to map the pain system and identify different phenotypes of pain response. Participants will undergo QST alongside standardized questionnaires assessing pain, depression, anxiety, and quality of life. Follow-up testing will be conducted for those undergoing endoscopic or surgical therapy to assess changes in their pain profile over time.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with chronic pancreatitis or those with abdominal pain and no pancreatic disease.

Not a fit: Patients with pancreatic disease who do not experience abdominal pain or those unable to comply with study procedures may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized treatment strategies for patients suffering from chronic pancreatitis.

How similar studies have performed: Other studies utilizing similar sensory testing techniques have shown promise in understanding pain mechanisms, suggesting potential for success in this novel application.

Eligibility criteria

Inclusion Criteria:

1. Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.

   * Subjects are 18 years or older in age
   * Subjects must be able to read and understand the study information.
   * Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
   * Subject is willing and able to comply with the scheduled visits, questionnaires, treatment plan, and other study procedures.
2. Suspected CPs Inclusion Criteria

   * Subjects are 18 years or older in age
   * Subjects with a) Indeterminate CP (Cambridge 1 or 2 on CT scan or MRI/MRCP) who have abdominal pain without prior history of AP, or b) those with acute (AP) or recurrent acute pancreatitis (RAP) who have recovered from their attack(s) of AP, whose imaging studies are either normal or show changes consistent with Cambridge classification of 1 or 2, and they have ongoing abdominal pain. Both diabetic and non-diabetic subjects will be allowed to enter the study.
   * Subjects must be able to read and understand the study information.
   * Subjects must suffer from abdominal pain suspected to be pancreatic origin with an intensity above 3 on the visual analogue scale (VAS, where 0=no pain and 10= intolerable pain), and meet the criteria for chronic pain (pain ≥ 3 days per week for at least 3 months).
   * Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
   * Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
3. Definite Chronic Pancreatitis - Inclusion Criteria

   * Subjects are 18 years or older in age
   * Subjects will have a prior confirmed diagnosis of CP on CT scan or MRI/MRCP according to Cambridge Classification (grade 3 or 4). Both diabetic and non-diabetic subjects will be allowed to enter the study.
   * Subjects must be able to read and understand the study information.
   * Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
   * Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.
4. Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Inclusion Criteria

   * Subjects are 18 years or older in age
   * Subjects have prior diagnosis of Type 1 or Type 2 Sphincter of Oddi Dysfunction (subjects with biliary pain accompanied by biochemical features of transient biliary tract obstruction including elevated transaminases, alkaline phosphatase, or conjugated bilirubin; may also be accompanied by biliary or pancreatic ductal dilation on imaging)
   * Subjects must be able to read and understand the study information.
   * Personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
   * Subjects willing and able to comply with the scheduled visits, questionnaires, and other study procedures.

Exclusion Criteria:

1. Subjects with no pancreatic disease and no abdominal pain, or patients with a diagnosis of functional dyspepsia.

   * Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
   * Subjects suffering from painful conditions that make them unable to distinguish the pain associated with CP from chronic pain of other origins.
   * Subjects with known pregnancy at the time of enrolment.
   * Subjects who have previously undergone surgical intervention on their pancreas.
2. Suspected CPs Exclusion Criteria

   * Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
   * Subjects suffering from painful conditions other than pancreatitis or SOD type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
   * Subjects with known pregnancy at the time of enrolment.
   * Subjects who have previously undergone surgical intervention on their pancreas.
3. Definite Chronic Pancreatitis Exclusion Criteria

   * Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
   * Subjects suffering from painful conditions other than pancreatitis or SOD type 1 or 2 that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
   * Subjects with known pregnancy at the time of enrolment.
   * Subjects who have previously undergone surgical intervention on their pancreas.
4. Sphincter of Oddi Dysfunction (SOD) Type 1 or Type 2 Exclusion Criteria

   * Subjects with evidence or history of medical or surgical disease of importance for this study as judged by investigator.
   * Subjects suffering from painful conditions other than pancreatitis or SOD that make them unable to distinguish the pain associated with pancreatitis or SOD from chronic pain of other origins.
   * Subjects with known pregnancy at the time of enrolment.
   * Subjects who have previously undergone surgical intervention on their pancreas.

Where this trial is running

Baltimore, Maryland and 1 other locations

• Johns Hopkins Medical Institutions — Baltimore, Maryland, United States (RECRUITING)
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States (RECRUITING)

Study contacts

• Principal investigator: Anna Evans-Phillips, MD — University of Pittsburgh
• Study coordinator: Anna Evans-Phillips, MD

Conditions: Chronic Pancreatitis, Chronic Pain, Sphincter of Oddi Dysfunction, Recurrent Acute Pancreatitis, Chronic Abdominal Pain, Functional Dyspepsia